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Adocia’s partner Tonghua Dongbao gets China NMPA nod to begin phase 3 trial of Ultra-Rapid Insulin BioChaperone Lispro to treat type 1 & type 2 diabetes

Lyon, France
Saturday, October 16, 2021, 18:00 Hrs  [IST]

Adocia, a clinical stage biopharmaceutical company, announced that its partner Tonghua Dongbao Pharmaceutical Co. Ltd. received clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the phase 3 clinical trial of BioChaperone Lispro, an Ultra-Rapid Insulin for the treatment of Type 1 and Type 2 diabetes. The first patient enrolled in the programme will trigger a milestone payment to Adocia.

“We are delighted to enter into the Phase 3 program for one of the two products licensed to Tonghua Dongbao, the domestic insulin leader in China," commented Gerard Soula, president & CEO of Adocia.

Adocia out-licensed BC Lispro to Tonghua Dongbao who is responsible for clinical development, manufacturing, product registration and future commercial operations in China and other Asian territories. The total amount perceived for this agreement could reach $45 million (including $10 million upfront payment) and double-digit royalties on sales. In parallel, Adocia is looking for other commercial partners in the US and in Europe for BC Lispro.

Dr. Chunsheng Leng, CEO of Tonghua Dongbao said, “This is an exciting time for us. Based on the strong positive phase 1 clinical trial results in Europe, delivered by our partner Adocia, we have been able to apply for and now receive CDE clearance to initiate this phase 3 programme. These studies will be run in parallel with the ongoing phase 1 trial and will greatly shorten our clinical study time. We hope that BC Lispro, this new generation insulin product, will bring a great value for people with diabetes in China, plus the rest of the world.”

Previous BC Lispro clinical studies demonstrated improved glycemic control compared to Humalog (Eli Lilly and Company) characterized by less hyperglycemia and hypoglycemia in meal tests. Hyperglycemia and hypoglycemia are responsible for long-term complications associated with diabetes. BC Lispro has demonstrated good tolerance similar to the standard of care, Humalog and Novolog. The primary objective of the phase 3 program is to demonstrate the non-inferiority of BC Lispro on HbA1c reduction from baseline vs. Humalog ; the secondary objective is superiority of BC Lispro on post-prandial glycemic control.

“I would like to warmly thank our partner Tonghua Dongbao for this fruitful collaboration, leading BC Lispro - the next generation insulin product - to Chinese people with diabetes which represent 1 in 4 in the World,” said Olivier Soula, deputy CEO of Adocia, “This is a great milestone for Adocia, proving our abilities to develop our products through latest stages together with partners and paving the way to bring this product worldwide.”

In China, the prandial market represents $1.4 billion. The fast-acting insulin market segment is the fastest growing with 16% YoY in 2019 (iQVia, May 2021).

BioChaperone Lispro (BC Lispro) is an ultra-rapid prandial insulin containing insulin lispro and Adocia’s proprietary technology BioChaperone. The BioChaperone excipient ensures a faster absorption of insulin. BC Lispro has demonstrated a faster action profile and improved performance compared to insulin analog lispro (Humalog, Eli Lilly) and insulin analog aspart (Novolog, Novo Nordisk), in nine Phase 1 & 2 studies in people with type 1 and type 2 diabetes, administered either by syringes or insulin pumps.

In a study using insulin pumps, BioChaperone Lispro showed a significantly faster-off effect compared to the Novo Nordisk Ultra-Rapid Insulin Fiasp and similar ultra-rapid onset of action.

Adocia’s partner Tonghua Dongbao is one of the leading insulin providers in Asia. Being a domestic player in diabetes innovation, Tonghua Dongbao is well positioned in the Ultra-Rapid Insulin market. Over one in four diabetic patients in the world is in China.

In 2018, Adocia and partner Tonghua Dongbao signed a strategic alliance to develop and commercialize BC Lispro in China and other Asian territories. Tonghua Dongbao also supplies insulin lispro and insulin glargine to Adocia for the worldwide market, except China. This supply allows Adocia to progress its own BC Lispro and BC Combo programmes and expand its partnership opportunities. Adocia retains development rights for BC Lispro in many territories such as (but not limited to) : the USA, Europe, Japan and Latin America. BC Lispro is ready for out-licensing in these territories.

Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of therapeutic proteins and peptides for the treatment of diabetes and metabolic diseases.

 

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